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Comprehensive Management of Diabetic Patients With Renal Impairment : Impact on Blood Pressure and Glycemic Control

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ClinicalTrials.gov Identifier: NCT00306436
Recruitment Status : Unknown
Verified June 2007 by University Hospital, Bordeaux.
Recruitment status was:  Recruiting
First Posted : March 23, 2006
Last Update Posted : June 13, 2007
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux

Brief Summary:
Diabetes is the leading cause of end-stage renal disease in developed countries. Hypertension and metabolic control are known to affect the progression of renal deficiency and patient's outcome. Our project aims at implementing a multidisciplinary and systematic approach of diabetic patients with renal deficiency, and at evaluating the impact of metabolic and blood pressure targets as recommended by current guidelines.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Procedure: comprehensive management Not Applicable

Detailed Description:

Complications of diabetes are influenced by the quality of blood pressure control and of metabolic control. Several prospective studies have shown a positive effect of the implementation of such control, however metabolic and blood pressure targets are not achieved for about 30% of diabetic uremic patients.

Our project aims at evaluating a comprehensive management approach of diabetic patients affected by renal insufficiency, defined by glomerular filtration rate (GRF) <60 mL/min/1,73 m², through an alternate and complementary follow-up by the nephrologist and the diabetologist.

During a first period (one year), patients are managed as “usually”. After this period, the patients will start the multidisciplinary health care during at least two years. They will be followed-up by the diabetologist every 4 months. According to his GFR measured by renal clearance of Cr-EDTA, the patient will be followed-up by the nephrologist every year if the GFR is between 60 and 40 ml/min, every 4 months if the GFR is between 40 and 20 ml/min, and every 1 or 2 months if the GFR is under 20 ml/min. GFR will be re-evaluated every year (Cr-EDTA or Cockcroft-Gault formula) and so medical examination frequency. Guidelines will be applied regarding blood pressure control (objective: < 135/85 mmHg, and < 125/75 mmHg if proteinuria > 1g/24H, choice of drugs, implementation of the treatment...) and glycemic control (current guidelines according to the French Health Technology Information Agency, ANAES). Another important component of the management will be the implementation of nutritional balance and foot care.

Every two years, a detailed nutritional checkup will be planned by the diabetologist and a cardiologic check-up will be planned by the nephrologist during one day in the local nephrology department.

A biobank will be built up after patient's consent. We will assess the impact of this intervention (guidelines application + multidisciplinary methodical and complementary follow-up) in terms of glycemic and blood pressure control.

The percentage of patients who will obtain a good glycemic and blood pressure control will be analysed and compared between the two follow-up period (before/after the intervention).

If validated this strategy may provide the basis of a care network focused on an optimum diabetic health care.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of the Impact of a Comprehensive Clinical Management on the Quality of Blood Pressure and Glycemic Control in Diabetic Uremic Patients
Study Start Date : May 2006
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. composite criteria reflecting a good glycemic and arterial pressure status. Success defined by all measurements of HbA1c < 6.5% and of systolic (diastolic) pressure <=135 (85) mmHg if proteinuria is < 1g/24h or <= 125 (75) if proteinuria is => 1g/24h


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic patients affected by renal insufficiency defined by glomerular filtration rate < 60 ml/min/1,73 m² by the Cockcroft-Gault formula
  • signed informed consent

Exclusion Criteria:

  • pregnant woman
  • minors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306436


Contacts
Contact: Catherine Lasseur, doctor 33 (0) 5 56 79 55 37 catherine.lasseur@chu-bordeaux.fr

Locations
France
Service de Néphrologie-Hémodialyse du Pr C.Combe, Hôpital Pellegrin, Place Amélie Raba-Léon Recruiting
Bordeaux cedex, France, 33076
Contact: Catherine Lasseur, Doctor    33 (0) 5 56 79 55 37    catherine.lasseur@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Investigators
Principal Investigator: Catherine Lasseur, Doctor University Hospital, Bordeaux
Study Chair: Geneviève Chêne, Professor University Hospital, Bordeaux

ClinicalTrials.gov Identifier: NCT00306436     History of Changes
Other Study ID Numbers: 9286-01
2001-027
First Posted: March 23, 2006    Key Record Dates
Last Update Posted: June 13, 2007
Last Verified: June 2007

Keywords provided by University Hospital, Bordeaux:
Diabetes
renal deficiency
hypertension

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases